DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/19/2022 and 01/10/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character in FIG. 1 not mentioned in the description: 116.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign mentioned in the description:
Paragraph [0057], [0058]: network 10 (according to the specification in FIG. 1)
Paragraph [0058]: institutional patient care system 300
Paragraph [0060]: pharmacy system 34
Paragraph [0068]: direct network connection 54 (according to the specification in FIG. 1)
Paragraph [0068]: decision support 48
Paragraph [0068]: remote data server 49
Paragraph [0068]: hospital department or unit stations 46
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because of the following informalities:
In paragraph [0020], the reference number 114 is used to describe “a range”. However, previously in paragraph [0017] the reference number 114 was used to describe “an infusion set”. It is unclear to the examiner which is the correct part for the reference number 114.
In paragraphs [0044]-[0046] and [0049]-[0050], the reference numbers suddenly appear within parentheses. All other reference numbers through the specification do not appear within parentheses. All reference numbers should be presented in the same format for continuity purposes.
In paragraph [0044], the specification states “Even though the pump's pumping speed is increased, it is increased to maintain the actual flow rate (132) it would have had, had the default condition remained…”. The sentence should be modified to fix a redundancy error.
In paragraph [0048], the reference number 114 is used to describe “an area”. However, previously in paragraph [0017] the reference number 114 was used to describe “an infusion set”. It is unclear to the examiner which is the correct part for the reference number 114.
In paragraph [0057], [0066], and [0068], the reference number 12 is used to describe “the patient care device” and “element”. However, previously in paragraph [0016] the reference number 12 was used to describe “a medical device”. Although paragraph [0057] does state “the patient care device (or “medical device” generally)”, paragraph [0057] also uses reference number 500 to describe “a patient care device”. It is unclear to the examiner which is the correct part for the reference number 12.
In paragraph [0063], the specification states “…or as detailed in Eggers et al.”. However, there was no inclusion of a reference under that name previously mentioned in the specification, or in the IDS. The examiner cannot make proper sense of the included reference, if no mention has been made or included in the application.
In paragraph [0066], the reference number 10 is used to describe “a patient care device”, or possible “a patient care device’s location”. However, previously in paragraph [0057] the reference number 10 was used to describe “a network”. It is unclear to the examiner which is the correct part for the reference number 10, as well as what exactly that number is referencing.
Appropriate correction is required.
In paragraph [0068], the reference number 54 is used to describe “direct network connection”. However, previously in paragraph [0059] the reference number 54 was used to describe “a user interface device”. It is unclear to the examiner which is the correct part for the reference number 54.
In paragraph [0070], the specification states “terminal device 32”, but previously this part has been written “device terminal 32”. A modification should be made for continuity purposes.
In paragraph [0071], the specification states “an input device interface 614”. However, according to FIG. 6, the reference number for “input device interface” should be 414.
The use of the term Bluetooth, which is a trade name or a mark used in commerce, has been noted in this application (see paragraphs [0061], [0068], and [0077]). The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claim 4 is objected to because of the following informalities: In the fourth line of the claim, the claim states “an intravenous tube of the infusion set”. It is unclear to the examiner if this “intravenous tube” is the same as previously mentioned in claim 2, upon which claim 4 is dependent. If the tubes are the same, for continuity purposes, the claim 4 should be modified to state “the intravenous tube of the infusion set”. If the tubes are different, the examiner suggest adding additional description to the claim to differ the tubes. Appropriate correction is required.
Claim objected to because of the following informalities: In the fifth line of the claim, the claim states “an intravenous tube of the infusion set”. It is unclear to the examiner if this “intravenous tube” is the same as previously mentioned in claim 13, upon which claim 14 is dependent. If the tubes are the same, for continuity purposes, the claim 14 should be modified to state “the intravenous tube of the infusion set”. If the tubes are different, the examiner suggest adding additional description to the claim to differ the tubes. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. In the second and fifth lines of the claim, the claim states “receiving a catheter size of a catheter”. This phasing renders the claim indefinite as it is unclear to the examiner what “a catheter size of a catheter” is. The examiner suggest modifying the language to present the limitation in a clearer manner. For the purposes of examination, the examiner will interpret the limitation to mean the device receives a portion of a catheter. Further, within the same claim the applicant refers to a catheter and a tube. Using both terms leads to confusion as to how many catheter or tubes are being used with the device. The examiner suggest modifying the language for continuity purposes. For the purposes of examination, the examiner will interpret the catheter and tube to be the same.
Claim 12, 19, and 20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 12 recites the limitation "the infusion device" in the second line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the infusion pump" in the fourteenth line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "the infusion pump" in the second and third lines of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the infusion pump" in the third. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. In the third and sixth lines of the claim, the claim states “receiving a catheter size of a catheter”. This phasing renders the claim indefinite as it is unclear to the examiner what “a catheter size of a catheter” is. The examiner suggest modifying the language to present the limitation in a clearer manner. For the purposes of examination, the examiner will interpret the limitation to mean the device receives a portion of a catheter. Further, within the same claim the applicant refers to a catheter and a tube. Using both terms leads to confusion as to how many catheter or tubes are being used with the device. The examiner suggest modifying the language for continuity purposes. For the purposes of examination, the examiner will interpret the catheter and tube to be the same.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 12, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kamen et al. (United States Patent Application Publication No. US 2016/0097382 A1; herein, Kamen), and further in view of Kamen et al. (United States Patent Application Publication No. US 2012/0185267 A1; herein, Kamen (2).
Regarding claim 1, Kamen discloses a method, comprising:
monitoring a delivery condition associated with an infusion pump or a medication during or prior to an administration of the medication to a patient by the infusion pump (FIG. 2, [0307], [0312]-[0317] infusion site monitor 26 monitors air presence, pressure, and various temperatures);
receiving an identification of an infusion set associated with the administration of the medication ([0305], infusion pump 19 may have scanner that interrogates RFID tag 29 to determine, among other things, if the infusion pump 19 and fluid reservoir 2 are correct);
determining, based on the identification of the infusion set and the monitored delivery condition, an operating characteristic representative of how the infusion set operates differently in view of the monitored delivery condition than under normal operating conditions ([305] discloses the operating parameters relative to each fluid reservoir, [0308] & [0312]-[0317] disclose components of infusion site monitor 26 (FIG.2) are connected to processor 37, which takes inputs, or operating characteristics, from components and communicates to other parts of system 1 (like FIG. 1 or FIG. 3));
identifying an operating parameter programmed to the infusion pump to administer the medication to the patient and which requires adjustment in view of the operating characteristic ([0312]-[0317], components of infusion site monitor 26 have predetermined thresholds that processor 37 monitors and determines when thresholds have been exceeded).
Kamen does not disclose automatically adjusting the identified operating parameter based on the determined operating characteristic representative of how the infusion set operates differently in view of the monitored delivery condition than under normal operating conditions.
However, Kamen (2) teaches automatically adjusting the identified operating parameter based on the determined operating characteristic representative of how the infusion set operates differently in view of the monitored delivery condition than under normal operating conditions ([0309] “the monitoring client 1 may be programmed to interrupt or adjust the infusion pump 7 flow rate, operating parameter, and/or treatment parameter depending on the value of the reading received from a monitoring device 14-17”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Kamen to automatically adjust operating parameters based on how the infusion set operates differently under the monitored delivery conditions as taught by Kamen (2) in order to enable bidirectional communications between a processor and monitoring device, allowing the device to function without intervention by a provider or patient ([0309]).
Regarding claim 12, Kamen discloses an infusion system (FIG. 1, system 1) comprising:
a sensor (infusion site monitor 26 has multiple sensors which each monitor a specific component) configured to monitor a delivery condition associated with the infusion device or a medication during or prior to an administration of the medication to a patient by an infusion device (FIG. 2, [0307], [0312]-[0317] infusion site monitor 26 monitors air presence, pressure, and various temperatures); and
an infusion device (FIG. 1, infusion device includes all elements except monitoring client 6) comprising at least one processor (processor 37) and a non-transitory computer readable medium (memory 38) storing instructions that, when executed by the at least one processor, cause the infusion device to:
receive an identification of an infusion set associated with the administration of the medication ([0305], infusion pump 19 may have scanner that interrogates RFID tag 29 to determine, among other things, if the infusion pump 19 and fluid reservoir 2 are correct);
determine, based on the identification of the infusion set and the monitored delivery condition, an operating characteristic representative of how the infusion set operates differently in view of the monitored delivery condition than under normal operating conditions ([0308], [0312]-[0317], components of infusion site monitor 26 (FIG.2) are connected to processor 37, which takes inputs, or operating characteristics, from components and communicates to other parts of system 1 (like FIG. 1 or FIG. 3));
identify an operating parameter programmed to the infusion pump to administer the medication to the patient and which requires adjustment in view of the operating characteristic ([0312]-[0317], components of infusion site monitor 26 have predetermined thresholds that processor 37 monitors and determines when thresholds have been exceeded).
Kamen does not disclose automatically adjusting the identified operating parameter based on the determined operating characteristic representative of how the infusion set operates differently in view of the monitored delivery condition than under normal operating conditions.
However, Kamen (2) teaches automatically adjusting the identified operating parameter based on the determined operating characteristic representative of how the infusion set operates differently in view of the monitored delivery condition than under normal operating conditions ([0309] “the monitoring client 1 may be programmed to interrupt or adjust the infusion pump 7 flow rate, operating parameter, and/or treatment parameter depending on the value of the reading received from a monitoring device 14-17”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Kamen to automatically adjust operating parameters based on how the infusion set operates differently under the monitored delivery conditions as taught by Kamen (2) in order to enable bidirectional communications between a processor and monitoring device, allowing the device to function without intervention by a provider or patient ([0309]).
Regarding claim 20, Kamen discloses a non-transitory computer readable medium having instructions stored thereon (memory 38) that, when executed by a medical device (FIG. 1, infusion device includes all elements except monitoring client 6), cause the medical device to:
monitor a delivery condition associated with the infusion pump or a medication during or prior to an administration of the medication to a patient by the infusion pump (FIG. 2, [0307], [0312]-[0317] infusion site monitor 26 monitors air presence, pressure, and various temperatures);
receive an identification of an infusion set associated with the administration of the medication ([0305], infusion pump 19 may have scanner that interrogates RFID tag 29 to determine, among other things, if the infusion pump 19 and fluid reservoir 2 are correct);
determine, based on the identification of the infusion set and the monitored delivery condition, an operating characteristic representative of how the infusion set operates differently in view of the monitored delivery condition than under normal operating conditions ([0308], [0312]-[0317], components of infusion site monitor 26 (FIG.2) are connected to processor 37, which takes inputs, or operating characteristics, from components and communicates to other parts of system 1 (like FIG. 1 or FIG. 3));
identify an operating parameter programmed to the infusion pump to administer the medication to the patient and which requires adjustment in view of the operating characteristic ([0312]-[0317], components of infusion site monitor 26 have predetermined thresholds that processor 37 monitors and determines when thresholds have been exceeded).
Kamen does not disclose automatically adjusting the identified operating parameter based on the determined operating characteristic representative of how the infusion set operates differently in view of the monitored delivery condition than under normal operating conditions.
However, Kamen (2) teaches automatically adjusting the identified operating parameter based on the determined operating characteristic representative of how the infusion set operates differently in view of the monitored delivery condition than under normal operating conditions ([0309] “the monitoring client 1 may be programmed to interrupt or adjust the infusion pump 7 flow rate, operating parameter, and/or treatment parameter depending on the value of the reading received from a monitoring device 14-17”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Kamen to automatically adjust operating parameters based on how the infusion set operates differently under the monitored delivery conditions as taught by Kamen (2) in order to enable bidirectional communications between a processor and monitoring device, allowing the device to function without intervention by a provider or patient ([0309]).
Claims 2-6, and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kamen in view of Kamen (2) as applied to claim1 and 12 above, and further in view of Li (CN 110860008 A).
Regarding claim 2, in the modified method of Kamen, Kamen discloses the delivery condition is an environmental condition ([0312], [0314], [0317], air presence, pressure, and ambient temperature are all environmental conditions) and the operating parameter is a pump speed or a flow rate of the medication within an intravenous tube of the infusion set ([0310], flow rate at infusion site monitor 26 is measured).
Kamen does not disclose determining a real-time delivery pressure associated with the administration of the medication to the patient; and determining an infusion characterization parameter based on the real-time delivery pressure, the operating characteristic of the infusion set, and the measured environmental condition, and adjusting the operating parameter based on the operating characteristic of the infusion set comprises adjusting the operation parameter to account for a pressure variance in the infusion line due to the medication being infused through the infusion set at the environmental condition.
However, Li teaches determining a real-time delivery pressure associated with the administration of the medication to the patient (An infusion system utilizes “a pressure detecting device for real-time monitoring the infusion liquid pressure”); and determining an infusion characterization parameter (“first pressure detection signal”) based on the real-time delivery pressure, the operating characteristic of the infusion set, and the measured environmental condition (“the pressure detection device of the first pressure sensor 27” monitors real-time “infusion liquid pressure within the first cavity 14, and [transmits] the first pressure detection signal to the drive controller 25”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Kamen to determine real-time delivery pressure and create an infusion characterization parameter as taught by Li in order that the infusion amount not be limited and the accuracy of the infusion rate remain unaffected.
Kamen in view of Li still does not disclose adjusting the operating parameter based on the operating characteristic of the infusion set comprises adjusting the operation parameter to account for a pressure variance in the infusion line due to the medication being infused through the infusion set at the environmental condition.
However, Kamen (2) teaches adjusting the operating parameter based on the operating characteristic of the infusion set comprises adjusting the operation parameter to account for a pressure variance in the infusion line due to the medication being infused through the infusion set at the environmental condition ([0309] “the monitoring client 1 may be programmed to interrupt or adjust the infusion pump 7 flow rate, operating parameter, and/or treatment parameter depending on the value of the reading received from a monitoring device 14-17”. The monitoring device is providing infusion and patient data to the monitoring client, which then can adjust the flow rate of the infusion pump.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Kamen to adjust the operating parameter in regards to changes within the infusion line as taught by Kamen (2) in order to enable bidirectional communications between a processor and monitoring device or sensor, allowing the device to function without intervention by a provider or patient ([0309]).
Regarding claim 3, in the modified method of Kamen, Kamen does not disclose determining the real-time delivery pressure comprises measuring an upstream line pressure of the intravenous tube of the infusion set. However, Kamen (2) determining the real-time delivery pressure comprises measuring an upstream line pressure of the intravenous tube of the infusion set ([0257], [0260] upstream pressure being monitored). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the real-time delivery pressure measurement taught by Li as part of the modified method disclosed by Kamen to be measured at an upstream point as taught by Kamen (2) in order to determine if the treatment or condition is safe for the patient ([0257]) and be alert for potential occlusions ([0260]).
Regarding claim 4, in the modified method of Kamen, Kamen discloses receiving a catheter size of a catheter used in the administration of the medication (FIG. 3, [0320]-[0321], tube 56 connects to system 1 by pumps 19, 20, 21), wherein determining the real-time delivery pressure comprises estimating a fluid pressure within an intravenous tube of the infusion set based on the operating characteristic of the infusion set and the received catheter size of the catheter used in the administration of the medication ([0314], “The pressure sensor 33 can measure, estimate, and/or determine the amount of pressure entering, exiting and/or flowing through the infusion site monitor 26”. The tubing connects the infusion site monitor 26 with the pumps, and the readings collected by the pressure sensor 33 are communicated to the processor 37 which determines the action the device must take to regulate.).
Regarding claim 5, in the modified method of Kamen, Kamen discloses receiving a patient physiological parameter for the patient ([0316], “The patient temperature sensor 35 can measure, estimate, and/or determine the temperature of the patient 5.”), wherein the estimating of the fluid pressure is further based on the patient physiological parameter ([0316], “The temperature of the patient 5 may be used to determine the condition of the patient, compliance with a temperature affecting medication, or effect of a temperature affecting medication.” One having ordinary skill in the art would understand all these determinations can affect how the device choses to proceed with modifying fluid pressure.).
Regarding claim 6, in the modified method of Kamen, Kamen discloses receiving a medication identifier for the medication ([0304]-[0305] barcode, RFID tag 29, may include information regarding the contents of the fluid reservoir 2); determining, based on medication identifier, a medication characteristic of the medication ([0304]-[0306] RFID tag 29 indicates if the fluid is the correct fluid for the patient based on patient's condition, fluid within pump needs to correspond to the treatment programmed into the infusion pump); wherein the operating characteristic of the infusion set is also determined based on the identified medication characteristic ([0304]-[0306], One having ordinary skill in the art would understand that depending on what drug is being infusion, the device would function differently to meet the requirements of the treatment regime programmed).
Regarding claim 13, in the modified system of Kamen, Kamen discloses wherein the delivery condition is an environmental condition within the housing of the infusion device ([0312], [0314], [0317], air presence, pressure, and ambient temperature are all environmental conditions), and wherein the non-transitory computer readable medium stores instructions (memory 38), and the operating parameter is a pump speed or a flow rate of the medication within an intravenous tube of the infusion set ([0310], flow rate at infusion site monitor 26 is measured).
Kamen does not disclose the infusion device comprises a housing including a fluid path to receive at least a portion of the infusion set, wherein the sensor is disposed within the housing, determine a real-time delivery pressure associated with the administration of the medication to the patient; and determine an infusion characterization parameter based on the real-time delivery pressure, and adjusting the operating parameter based on the operating characteristic of the infusion set comprises adjusting the operation parameter to account for a pressure variance in the infusion line due to the medication being infused through the infusion set at the environmental condition.
However, Li teaches determining a real-time delivery pressure associated with the administration of the medication to the patient (An infusion system utilizes “a pressure detecting device for real-time monitoring the infusion liquid pressure”); and determining an infusion characterization parameter (“first pressure detection signal”) based on the real-time delivery pressure (“the pressure detection device of the first pressure sensor 27” monitors real-time “infusion liquid pressure within the first cavity 14, and [transmits] the first pressure detection signal to the drive controller 25”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system disclosed by Kamen to determine real-time delivery pressure and create an infusion characterization parameter as taught by Li in order that the infusion amount not be limited and the accuracy of the infusion rate remain unaffected.
Kamen in view of Li still does not disclose the infusion device comprises a housing including a fluid path to receive at least a portion of the infusion set, wherein the sensor is disposed within the housing, and adjusting the operating parameter based on the operating characteristic of the infusion set comprises adjusting the operation parameter to account for a pressure variance in the infusion line due to the medication being infused through the infusion set at the environmental condition.
However, Kamen (2) teaches the infusion device comprises a housing (FIG. 22) including a fluid path to receive at least a portion of the infusion set (FIG. 22, patient-care devices 2106, 2108, 2110 connect by tubing to rest of system), wherein the sensor is disposed within the housing (FIG. 22, patient-care devices 2106, 2108, 2110, 2112, 2114 house sensors), and adjusting the operating parameter based on the operating characteristic of the infusion set comprises adjusting the operation parameter to account for a pressure variance in the infusion line due to the medication being infused through the infusion set at the environmental condition ([0309] “the monitoring client 1 may be programmed to interrupt or adjust the infusion pump 7 flow rate, operating parameter, and/or treatment parameter depending on the value of the reading received from a monitoring device 14-17”. The monitoring device is providing infusion and patient data to the monitoring client, which then can adjust the flow rate of the infusion pump.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system disclosed by Kamen to have a housing for the infusion device and sensors, as well as adjust the operating parameter in regards to changes within the infusion line as taught by Kamen (2) in order to minimize the amount of devices use and enable bidirectional communications between a processor and monitoring device or sensor, allowing the device to function without intervention by a provider or patient ([0309]).
Regarding claim 14, in the modified system of Kamen, Kamen discloses receiving a catheter size of a catheter used in the administration of the medication (FIG. 3, [0320]-[0321], tube 56 connects to system 1 by pumps 19, 20, 21), wherein determining the real-time delivery pressure comprises estimating a fluid pressure within an intravenous tube of the infusion set based on the operating characteristic of the infusion set and the received catheter size of the catheter used in the administration of the medication ([0314], “The pressure sensor 33 can measure, estimate, and/or determine the amount of pressure entering, exiting and/or flowing through the infusion site monitor 26”. The tubing connects the infusion site monitor 26 with the pumps, and the readings collected by the pressure sensor 33 are communicated to the processor 37 which determines the action the device must take to regulate.).
Regarding claim 15, in the modified system of Kamen, Kamen discloses receiving a patient physiological parameter for the patient ([0316], “The patient temperature sensor 35 can measure, estimate, and/or determine the temperature of the patient 5.”), wherein the estimating of the fluid pressure is further based on the patient physiological parameter ([0316], “The temperature of the patient 5 may be used to determine the condition of the patient, compliance with a temperature affecting medication, or effect of a temperature affecting medication.” One having ordinary skill in the art would understand all these determinations can affect how the device choses to proceed with modifying fluid pressure.).
Regarding claim 16, in the modified device of Kamen, Kamen discloses receiving a medication identifier for the medication ([0304]-[0305] barcode, RFID tag 29, may include information regarding the contents of the fluid reservoir 2); determining, based on medication identifier, a medication characteristic of the medication ([0304]-[0306] RFID tag 29 indicates if the fluid is the correct fluid for the patient based on patient's condition, fluid within pump needs to correspond to the treatment programmed into the infusion pump); wherein the operating characteristic of the infusion set is also determined based on the identified medication characteristic ([0304]-[0306], One having ordinary skill in the art would understand that depending on what drug is being infusion, the device would function differently to meet the requirements of the treatment regime programmed).
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Kamen in view of Kamen (2) and Li as applied to claims 6 and 16 above, and further in view of Sage Jr. (United States Patent No. US 6,582,393 B2).
Regarding claim 7, in the modified method of Kamen, Kamen discloses the delivery condition comprises a temperature of an area proximate to the infusion pump or of the medication ([0317], ambient air temperature sensor 36).
Kamen does not disclose wherein the medication characteristic comprises a fluid viscosity at the temperature. However, Sage Jr. teaches wherein the medication characteristic comprises a fluid viscosity at the temperature (col. 9 lines 22-41, “it is a temperature change that causes the viscosity of the drug solution to change”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Kamen to specifically monitor viscosity changes as taught by Sage Jr. in order compensate for changes in fluid flow made by viscosity and accurately deliver the desired dose of a drug (col. 11 lines 39-62).
Regarding claim 17, in the modified device of Kamen, Kamen discloses the delivery condition comprises a temperature of an area proximate to the infusion pump or of the medication ([0317], ambient air temperature sensor 36).
Kamen does not disclose wherein the medication characteristic comprises a fluid viscosity at the temperature. However, Sage Jr. teaches wherein the medication characteristic comprises a fluid viscosity at the temperature (col. 9 lines 22-41, “it is a temperature change that causes the viscosity of the drug solution to change”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Kamen to specifically monitor viscosity changes as taught by Sage Jr. in order compensate for changes in fluid flow made by viscosity and accurately deliver the desired dose of a drug (col. 11 lines 39-62).
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kamen in view of Kamen (2) as applied to claims 1 and 12 above, and further in view of Hartlaub et al. (United States Patent Application Publication No. US 2010/0145271 A1; herein Hartlaub).
Regarding claim 8, in the modified method of Kamen, Kamen discloses the delivery condition comprises an ambient temperature or humidity of an area proximate to the infusion pump ([0317], ambient air temperature sensor 36), and a temperature of the medication ([0315], fluid-temperature sensor 34).
Kamen does not disclose wherein the operating characteristic of the infusion set is based on a performance characterization of the infusion set at the temperature or humidity.
However, Hartlaub teaches wherein the operating characteristic of the infusion set is based on a performance characterization of the infusion set at the temperature or humidity ([0031]-[0039], “Temperature data values read from the temperature sensor might be stored in memory to be read out or analyze at a later time”. Temperature of both the patient and ambient can be continuously monitored and store for reference.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Kamen to monitor a performance characterization of the infusion set as taught by Hartlaub in order to monitor the effectiveness of the therapy or to help the healthcare provider decide to adjust the infusion rate dependence on a patient's body temperature ([0041]).
Regarding claim 18, in the modified device of Kamen, Kamen discloses the delivery condition comprises an ambient temperature or humidity of an area proximate to the infusion pump ([0317], ambient air temperature sensor 36), and a temperature of the medication ([0315], fluid-temperature sensor 34).
Kamen does not disclose wherein the operating characteristic of the infusion set is based on a performance characterization of the infusion set at the temperature or humidity.
However, Hartlaub teaches wherein the operating characteristic of the infusion set is based on a performance characterization of the infusion set at the temperature or humidity ([0031]-[0039], “Temperature data values read from the temperature sensor might be stored in memory to be read out or analyze at a later time”. Temperature of both the patient and ambient can be continuously monitored and store for reference.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Kamen to monitor a performance characterization of the infusion set as taught by Hartlaub in order to monitor the effectiveness of the therapy or to help the healthcare provider decide to adjust the infusion rate dependence on a patient's body temperature ([0041]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kamen in view of Kamen (2) as applied to claim 1 above, and further in view of Baba et al. (United States Patent No. 5,898,557 A; herein, Baba).
Regarding claim 9, in the modified method of Kamen, Kamen does not disclose the delivery condition comprises a circuit temperature associated with circuitry within the infusion pump. However, Baba teaches the delivery condition comprises a circuit temperature associated with circuitry within the infusion pump (FIG. 1, col. 4 lines 23-36, “semiconductor switch 32 is kept at a relatively high temperature, a heat therefrom would transfer to other circuitry, thus causing an increase in temperature of the circuits such as a driver 33, over-current detection circuits 34 and 35 etc.”, a temperature detection circuit 111 is used to monitor the temperature inside the housing across all electrical components). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Kamen to monitor a circuit temperature as taught by Baba in order to prevent the circuits from being thermally deteriorated or affected due to the heat (col. 19 line 64 – col. 20 line 3).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Desch et al. (United States Patent Application Publication No. US 2015/0157791 A1) is considered relevant prior art with regards to a syringe pump having a memory and processor that execute instructions and determine the state of the device.
Zhu (United States Patent Application Publication No. US 2014/0207057 A1) is considered relevant prior art with regards to an infusion pump with sensors that store at least one characteristic value relating to a status of the infusion pump
O’Connor et al. (United States Patent Application Publication No. US 2020/0101225 A1) is considered relevant prior art with regards to an artificial pancreas system that can be activated automatically by a controller.
Carothers et al. (United States Patent Application Publication No. US 2019/0117891 A1) is considered relevant prior art with regards to a system for detecting pressure within a tube while utilizing a non-transitory computer readable medium.
Williams et al. (United States Patent No. US 8,444,592 B2) is considered relevant prior art with regards to a fluid management system with pressure control and flow control modes.
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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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